Effects of Music Based Intervention (MBI) on Pain Response and Neurodevelopment in Preterm Infants

Not Applicable

Completed

• Conditions: Preterm Birth; Pain
• Interventions: Other: Music Based Intervention; Other: Sham Treatment

• Registration Number: NCT04286269
• Lead Sponsor: University of Minnesota

Brief Summary

Pilot prospective randomized, double blinded, controlled study to test effect of music based intervention (MBI) on pain response and neurodevelopment in preterm infants.

Detailed Description

Aim 1: Premature infant pain profiles (PIPP) include physiologic, behavioral, and contextual measures which identifies differences in pain responses between music-based intervention (MBI) and controls while still in the neonatal intensive care unit (NICU). Central EEG amplitude changes have been time-locked with painful procedures in term infants. We will explore if PIPP scores and central EEG amplitude changes are attenuated with MBI in comparison to controls.

Hypothesis 1: MBI will show improved pain responses, with lower PIPP scores and attenuated central EEG amplitude changes during painful procedures, in comparison to the control cohort.

Aim 2: EEG is a surrogate marker for real time brain function during sleep-wake cycles. Because preterm brain networks develop during sleep, sleep duration is a strong indicator of brain maturation. Serial biweekly EEGs of preterm infants can quantify sleep duration trends and track MBI's influence on sleep. To enhance objectivity, innovative EEG machine-learning tools will be applied to the analyses.

Hypothesis 2: MBI will enhance preterm EEG brain maturation in comparison to controls.

Due to the natural limitations of evaluating immature neonatal nervous systems, ERPs have been utilized to study early neurodevelopment. ERPs quantify electrical brain potentials changes time-locked with a stimulus. Auditory ERPs performed at 1 month corrected age evaluates attention and discrimination between familiar and novel stimuli - early neurodevelopmental signs of recognition memory function and perceptual learning.

Hypothesis 3: ERPs at 1 month corrected age will show that MBI has a greater impact on early neurodevelopment when compared to controls.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-26
• Study Start: 2020-11-20
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Preterm infant born at 30 weeks (+/- 2 weeks)
• Medically stable

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Exclusion Criteria

• Treatment for major organ system disease
• Significant neurological disorder including, but not limited to, abnormal neurological examination, neonatal abstinence syndrome, intraventricular hemorrhage, seizures, meningitis, or congenital brain malformations
• Scalp lesions affecting EEG placement

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Music Based Intervention	Participants in this group will be randomized to receive the intervention.
Placebo	Sham Treatment	Participants in this group will be randomized to receive a sham treatment.

Primary Outcome Measures

Name	Time	Method
Central Electroencephalography (EEG) Amplitude	6 weeks	EEG will be recorded in 30-hour sessions. Central amplitude will be reported in microvolts.
Premature Infant Pain Profile (PIPP) Score	6 weeks	The Premature Infant Pain Profile (PIPP) is a pain scoring system assessing 7 indicators: observed change in heart rate, observed decrease in percent oxygen saturation; observed facial expressions of pain (brow bulge, eye squeeze, and naso-labial furrow); gestational age; and behavioral state. Clinicians rate each indicator on a scale from 0 to 3 using a set scoring system. Total scores range 0 to 21, with higher scores indicating greater pain.
Event Related Potential (ERP) Amplitude	6 weeks	ERP will be measured during EEG as a measure of neurodevelopment and reported in microvolts.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States